Lotilaner
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2017
- First approval year
- 2017
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Lotilaner
- Molecular weight
- 596.76
- Structure (SMILES)
- Cc1cc(C2=NO[C@@](c3cc(Cl)c(Cl)c(Cl)c3)(C(F)(F)F)C2)sc1C(=O)NCC(=O)NCC(F)(F)F
- Adtab (previously lotilaner elanco)
- adtab previously lotilaner elanco
- credelio
- Credelio
- lotimax
- Lotimax
- xdemvy
- Xdemvy
- credelio
- Credelio
- lotilaner
- Lotilaner
- Lotilaner (ema epar: veterinary)
- LOTILANER [GREEN BOOK]
- lotilaner [INN]
- LOTILANER [MI]
- LOTILANER [USAN]
- Lotilaner [WHO-DD]
- lotilaner ema epar veterinary
- lotilaner green book
- lotilaner inn
- lotilaner mi
- lotilaner usan
- lotilaner who dd
- TP-05 (lotilaner oral capsules)
- TP-05 (lotilaner) High Dose
- TP-05 (lotilaner) Low Dose
- Xdemvy
- ATC classification codes
- S01AX25
Sources for recorded values
- CAS registry numbers
- 1369852-71-0
- ChEMBL ID
- CHEMBL3707310
- InChIKey
- HDKWFBCPLKNOCK-SFHVURJKSA-N
- PubChem compound IDs
- 76959255
- RxNorm IDs (RxCUI)
- 1998841
- FDA ingredient codes (UNII)
- HEH4938D7K
- Applicant
- TARSUS
- Approval date
- 24 Jul 2023
- Application number
- NDA217603
- Patents
- 9
- Designations
- 0
- Earliest recorded loss of exclusivity
- 14 Dec 2038
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Drug name stem
- -laner
Administration routes
- topical
- Condition
- Blepharitis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0009536
- Subject identifier
- D001762
- Condition
- Rosacea
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000760
- Subject identifier
- D012393
- Condition
- Eye Infections
- Highest recorded phase
- 4
- Condition identifier
- EFO:1001888
- Subject identifier
- D015817
- Condition
- Eye Infections, Parasitic
- Highest recorded phase
- 4
- Condition identifier
- EFO:1001888
- Subject identifier
- D015822
- Condition identifier
- EFO_0009536
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000760
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001888
- Condition identifier
- EFO_1001888
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004785
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005101
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005980
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0006604
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0015459
- Condition identifier
- MONDO_0015459
- Highest recorded phase
- 4
- NCT04475432
- NCT04784091
- NCT05629390
- NCT05838170
- Dose
- 6 mg/kg
- Route
- Oral
- How often
- Once a month
Conditions of use
- Administer with food
- Hydrogen bond acceptors
- 5
- Hydrogen bond donors
- 2
- Polar surface area
- 79.79
- Calculated partition coefficient (ALogP)
- 6.01
- Calculated partition coefficient (XLogP)
- 6.6
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 2
- Rotatable bonds
- 6
- Heavy atoms
- 36
- Molecular formula
- C20H14Cl3F6N3O3S
- Monoisotopic mass
- 594.972565
- Natural product
- No
- 81942-125
- Recorded assays
- 2
- Active assays
- 1
Active assay types
- Confirmatory
- Antiparasitic Agents
Related records
Trials (9)
- A Pharmacokinetic Study of TP-05 in Healthy Subjects
- A Six Week Pharmacokinetic Study of TP-03 in Healthy Subjects
- A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure
- Demodex Blepharitis in Scleral Lens Wearers
- Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers
- Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE)
- Study of TP-04 in Participants With Papulopustular Rosacea
- Study to Evaluate the Food Effect of TP-05 in Healthy Participants
- Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study
Approved for (2)
- Eye infectious disorder
- Parasitic eye infection
In development for (2)
- Blepharitis Phase 3
- Rosacea Phase 2